UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
For
the month of November, 2023
Commission
File Number: 001-36000
XTL
Biopharmaceuticals Ltd.
(Translation
of registrant’s name into English)
26
Ben Gurion St.
Ramat
Gan,
4365603,
Israel
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
RAMAT
GAN, ISRAEL - (November 15, 2023) – XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) (“XTL” or
the “Company”), a clinical-stage biopharmaceutical Company, today announced financial results for the nine months ended September
30, 2023.
The
Company has an IP portfolio surrounding hCDR1 for the treatment of Lupus disease (SLE) and Sjögren’s Syndrom (SS). The Company
has decided to explore collaboration with a strategic partner. In parallel, the Company is looking to expand and identify additional
assets to add to XTL’s portfolio.
We
are currently operating in a period of economic uncertainty and capital markets disruption. Our business, financial condition and results
of operations may be materially adversely affected by any negative impact on the global economy and capital markets resulting from any
geopolitical tensions.
To
date, the Company's management confirms that the Company has not seen any material impact on its ongoing operations in Israel and its
ability to continue searching for new assets, aside from a negative effect on our marketable securities and potentially our ability to
raise additional funds if needed. At the same time, the Company continues to monitor its ongoing activities and make any needed adjustments
to ensure a smooth continuity of its business. The Company notes that its headquarters are in the center of the country, near Tel Aviv,
and not near any borders.
Financial
Overview for Nine Months Ended September 30, 2023
XTL
reported approximately $1.46 million in cash and cash equivalents and approximately $0.75 million in marketable securities as of September
30, 2023, compared to $2.1 million in cash and cash equivalents and approximately $1.6 million in marketable securities as of December
31, 2022. The decrease in cash and cash equivalents of approximately $0.64 million since December 31, 2022, derives from operating expenses.
Research
and development expenses for the nine months ended September 30, 2023 were $25 thousand compared to $24 thousand for the corresponding
period in 2022. Research and development expenses are comprised mainly of expenses related to maintenance of our intangible assets.
General
and administrative expenses for the nine months ended September 30, 2023 were $540 thousand compared to $631 thousand for the corresponding
period in 2022. The decrease of $91 thousand derives mainly from lower insurance fee for our officers and directors.
Finance
expense, net for the nine months ended September 30, 2023 were $933 thousand compared to finance income, net of $55 thousand for the
corresponding period in 2022. The difference is primarily from revaluation of warrants to purchase ADS’s.
XTL
reported a loss for the nine months ended September 30, 2023 of $1,498 thousand compared to a loss of $600 thousand for the corresponding
period in 2022. The increase of $898 thousands in loss, derives mainly from the revaluation of warrants to purchase ADS’s in 2022.
XTL
Biopharmaceuticals, Ltd. and Subsidiary
(USD
in thousands)
Unaudited
Consolidated Statements of Financial Position - Selected Data
| |
September 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
U.S. dollars in thousands | |
ASSETS | |
| | |
| |
| |
| | |
| |
CURRENT ASSETS: | |
| | |
| |
Cash and cash equivalents | |
| 1,457 | | |
| 2,094 | |
Marketable securities – InterCure Ltd. | |
| 749 | | |
| 1,627 | |
Prepaid expenses and other current assets | |
| 77 | | |
| 85 | |
| |
| | | |
| | |
| |
| 2,283 | | |
| 3,806 | |
| |
| | | |
| | |
NON-CURRENT ASSETS: | |
| | | |
| | |
Intangible assets, net | |
| 380 | | |
| 380 | |
| |
| | | |
| | |
Total assets | |
| 2,663 | | |
| 4,186 | |
| |
| | | |
| | |
LIABILITIES AND EQUITY | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES: | |
| | | |
| | |
Accounts payable | |
| 162 | | |
| 187 | |
| |
| | | |
| | |
Total liabilities | |
| 162 | | |
| 187 | |
| |
| | | |
| | |
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | |
| | | |
| | |
Share capital - ordinary shares of NIS 0.1 par value: authorized shares - 1,450,000,000 on September 30, 2023 and December 31, 2022; issued and outstanding: 544,906,149 on September, 2023 and December 31, 2022; | |
| 14,120 | | |
| 14,120 | |
Additional paid in capital | |
| 146,326 | | |
| 146,326 | |
Reserve from transactions with non-controlling interests | |
| 20 | | |
| 20 | |
Accumulated deficit | |
| (157,965 | ) | |
| (156,467 | ) |
| |
| | | |
| | |
Total equity | |
| 2,501 | | |
| 3,999 | |
| |
| | | |
| | |
Total liabilities and equity | |
| 2,663 | | |
| 4,186 | |
XTL
Biopharmaceuticals, Ltd. and Subsidiary
(USD
in thousands, except per share amounts)
Unaudited
Consolidated Statements of Comprehensive Income (Loss) - Selected Data
| |
For the nine months ended | |
| |
September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Research and Development expenses | |
$ | (25 | ) | |
$ | (24 | ) |
General and administrative expenses | |
| (540 | ) | |
| (631 | ) |
Operating Loss | |
$ | (565 | ) | |
$ | (655 | ) |
| |
| | | |
| | |
Revaluation of marketable securities | |
$ | (878 | ) | |
$ | (997 | ) |
Revaluation of warrants to purchase ADS’s | |
| - | | |
| 1,054 | |
Other finance income | |
| 30 | | |
| 20 | |
Other finance expense | |
| (85 | ) | |
| (22 | ) |
| |
| | | |
| | |
Finance income (expenses), net | |
| (933 | ) | |
| 55 | |
| |
| | | |
| | |
Total comprehensive loss for the period | |
$ | (1,498 | ) | |
$ | (600 | ) |
| |
| | | |
| | |
Basic loss per share (in U.S. dollars): | |
| (0.003 | ) | |
$ | (0.001 | ) |
Diluted loss per share (in U.S. dollars): | |
| (0.003 | ) | |
$ | (0.001 | ) |
| |
| | | |
| | |
Weighted average number of issued ordinary shares (basic and diluted) | |
| 544,906,149 | | |
| 544,906,149 | |
About
hCDR1
hCDR1
is a novel compound with a unique mechanism of action and clinical data on over 400 patients in three clinical studies. The drug has
a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint.
For more information, please see the peer reviewed article in Lupus Science and Medicine journal titled “Safety and efficacy of
hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study”.
About
XTL Biopharmaceuticals Ltd. (XTL)
XTL
Biopharmaceuticals Ltd. is a clinical-stage biotech company. The Company’s lead drug candidate, hCDR1, is a clinical asset
for the treatment of autoimmune diseases including systemic lupus erythematosus (SLE) and Sjögren’s Syndrome (SS). The few
treatments currently on the market for these diseases are not effective enough for many patients and some have significant side effects.
hCDR1 has robust clinical data in three clinical trials with 400 patients and over 200 preclinical studies with data published in more
than 40 peer reviewed scientific journals.
XTL
is traded on the Nasdaq Capital Market (NASDAQ: XTLB) and the Tel Aviv Stock Exchange (TASE: XTLB.TA). XTL shares are included in
the following indices: Tel-Aviv Biomed, Tel-Aviv MidCap, and Tel-Aviv Tech Index.
For
further information, please contact:
Investor
Relations, XTL Biopharmaceuticals Ltd.
Tel:
+972 3 611 6666
Email:
ir@xtlbio.com
www.xtlbio.com
Cautionary
Statement
This
disclosure may contain forward-looking statements, about XTL’s expectations, beliefs or intentions regarding, among other things,
its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time
to time, XTL or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements
can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,”
“may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable
words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements
may be included in, but are not limited to, various filings made by XTL with the U.S. Securities and Exchange Commission, press releases
or oral statements made by or with the approval of one of XTL’s authorized executive officers. Forward-looking statements relate
to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate
to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause XTL’s
actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could
cause XTL’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking
statements, including, but not limited to, the factors summarized in XTL’s filings with the SEC and in its periodic filings with
the TASE. In addition, XTL operates in an industry sector where securities values are highly volatile and may be influenced by economic
and other factors beyond its control. XTL does not undertake any obligation to publicly update these forward-looking statements, whether
as a result of new information, future events or otherwise. Please see the risk factors associated with an investment in our ADSs or
ordinary shares which are included in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March
22, 2023.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
Date: November 15, 2023 |
XTL BIOPHARMACEUTICALS LTD. |
|
|
|
By: |
/s/
Shlomo Shalev |
|
|
Shlomo Shalev
Chief Executive Officer |
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